Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075896
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FELODIPINE | FELODIPINE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| FELODIPINE | FELODIPINE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| FELODIPINE | FELODIPINE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/02/2004 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/75896ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075896_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/13/2013 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/13/2013 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |